Sun Pharma is the world’s fourth largest specialty generic pharmaceutical company and No. 1 in India. We provide high-quality, affordable medicines trusted by customers and patients in over 100 countries. Sun Pharma’s global presence is supported by more than 40 manufacturing facilities spread across 5 continents, R&D centres across the globe and a multi-cultural workforce comprising over 50 nationalities. Sun Pharma fosters excellence through innovation supported by strong R&D capabilities comprising around 3,000 scientists and R&D investments of over 6-8% of annual revenues.
- Vacancy details:
- Department:Senior Executive
- Qualification:M.Sc. /B.Pharm/M.Pharm
- Experience:7-8 Years
Greetings from Sun Pharmaceutical Industries Ltd..!!!!
- Important Details :
- Location: Â Dadra – Plant
- Post of date:19/07/2024
- Selection Process: The selection will be on the basis of Interview.
- Mode of Interview: face to face
- Interview Rounds of Interview: HR
Areas Of Responsibility
Monitoring for Documents compilation activities for New product filing , Re-Registration/renewals from plant dossier filing , sample requirements etc.
Participation in Action plan discussion for queries from different Regulatory agencies and monitoring for submission of data/documents from plant.
Coordination with CRA, ADD, FDD, MSTG ,PMO ,Plant team and with other CFT Members for regulatory requirements related to Registration, Re-Registration.
Product Life Cycle Management: Active participation in Change control committee meeting. – Discussion with different Stakeholders and decision for final variation.
Activities related to Variation management – Tracking of Variation filing, approvals and intimation to plant for implementation of changes.
Support plant for business continuity of products by filing variations wherever applicable.
Monitoring for circulation of Regulatory Approvals and commitment details to Plant Team for US and OAM and Approval package for emerging market
Participation in all launch discussions with plant CFTÂ , business team , CRA to identify gap & mitigation plan.
Circulation of Regulatory strategies and Guidelines, wherever applicable.
Support plant during Regulatory Inspections.
